Systems and methods for implants and deployment devices

ABSTRACT

Benign prosthetic hyperplasia (BPH) is a non-cancerous enlargement of the prostate gland. Treatment options for BPH include medication, surgery (e.g., removal of enlarged prostate tissue), and minimally invasive procedures (e.g., needle ablation, electrovaporization, thermotherapy, and stent insertion). Minimally invasive procedure is typically the preferred choice if medication is ineffective. Accordingly, disclosed herein are system and method for treating BPH using improved implant and delivery device. Certain embodiments of the delivery device can include: a camming barrel having a first groove at the distal end of the camming barrel; a sheath, located within a lumen of the camming barrel, for storing the implantable device; and a first cam follower coupled to the sheath.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of PCT Application No.PCT/US17/28677, filed Apr. 20, 2017, which claims the benefit of andpriority to U.S. Provisional Application No. 62/325,939, filed Apr. 21,2016, both of which are incorporated by reference herein in theirentireties for all purposes.

FIELD

Various aspects of the disclosure relate to a system and method forimplants and deployment devices.

BACKGROUND

Benign prosthetic hyperplasia (BPH), also known as benign prostatichypertrophy, is a non-cancerous enlargement of the prostate gland. BPHis a condition that mainly occurs in older men. Treatment options forBPH include medication, surgery (e.g., removal of enlarged prostatetissue), and minimally invasive procedures (e.g., needle ablation,electrovaporization, thermotherapy, and stent insertion). Currently,most patients opt for surgical treatment if medication is ineffective.However, minimally invasive procedures are becoming increasingly popularand common. Accordingly, disclosed herein are systems and methods fortreating BPH using improved implants and deployment devices.

SUMMARY

Example embodiments of delivery devices and systems are disclosed, asare example embodiments of components of the systems and methods ofusing the systems and/or components thereof. Certain embodiments of thedelivery device can include: a camming barrel having a first groove atthe distal end of the camming barrel; a sheath, located within a lumenof the camming barrel, for storing the implantable device; and a firstcam follower coupled to the sheath. In some embodiments, the first camfollower is configured to travel within the first groove of the cammingbarrel and to translate the sheath, which causes the sheath to retractinto the camming barrel.

In some embodiments, the camming barrel can include a second groove thatis designed to translate a second cam follower coupled to a pushershaft. The translation of the second cam follower causes the pushershaft to be pushed in the distal direction to assist in deploying theimplantable device attached to the distal end of the pusher shaft. Thefirst groove can be disposed near the distal end of the camming barrel,and the second groove can be disposed near the proximal end of thecamming barrel. In some embodiments, each of the grooves can be formedby a plurality of linked helical and/or radial slots. In someembodiments, the first and second grooves can be arranged such that thefirst cam follower is traversing a helical slot of the first groovewhile the second cam follower of the second groove is concurrently orsimultaneously traversing a radial slot of the second groove. In thisway, the movements of both cam followers are not required to be the sameat every point of time. This enables two main types of coordinatedmovement of the cam followers. The first type of coordinated movement iswhen the first cam follower retracts the sheath in the proximaldirection while the second cam follower holds the pusher shaft axiallystationary. The second type of coordinated movement is when the firstcam follower holds the sheath axially stationary while the second camfollower pushes the pusher shaft forward in the distal direction.

Other systems, devices, methods, features and advantages of the subjectmatter described herein will be or will become apparent to one withskill in the art upon examination of the following figures and detaileddescription. It is intended that all such additional systems, methods,features and advantages be included within this description, be withinthe scope of the subject matter described herein, and be protected bythe accompanying claims. In no way should the features of the exampleembodiments be construed as limiting the appended claims, absent expressrecitation of those features in the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description, isbetter understood when read in conjunction with the accompanyingdrawings. The accompanying drawings, which are incorporated herein andform part of the specification, illustrate a plurality of embodimentsand, together with the description, further serve to explain theprinciples involved and to enable a person skilled in the relevantart(s) to make and use the disclosed technologies.

FIG. 1 depicts an example embodiment of an implantable device beingdeployed within a urethra.

FIGS. 2-3 are perspective views depicting example embodiments ofimplantable devices.

FIGS. 4A-4E depict an example deployment procedure of an implantabledevice in accordance with some embodiments of the disclosure.

FIG. 4F is a perspective view depicting an example embodiment of animplantable device contained within a sheath and attached to a pushershaft.

FIGS. 4G and 4H are perspective views depicting example embodiments of agrasper.

FIG. 5A is a perspective view depicting a delivery device in accordancewith some example embodiments of the present disclosure.

FIG. 5B is cross-sectional view depicting a portion of a delivery devicein accordance with some example embodiments of the present disclosure.

FIGS. 5C and 6A are perspective views depicting a delivery device inaccordance with some example embodiments of the present disclosure.

FIG. 6B is a side view depicting an example embodiment of deliverydevice.

FIGS. 7A-7B, 8A-8B, and 9 are perspective views depicting a deliverydevice in accordance with some example embodiments of the presentdisclosure.

FIGS. 10A-10N are side views depicting an example embodiment of adeployment procedure and the progression of the deployment.

FIG. 11 is a perspective view depicting a camming barrel in accordancewith some example embodiments of the present disclosure.

FIGS. 12A-12I are perspective views depicting a locking mechanism of thedelivery device in accordance with some example embodiments of thepresent disclosure.

FIG. 12J is a cross-sectional view depicting a locking mechanism of thedelivery device in accordance with some example embodiments of thepresent disclosure.

FIGS. 13 and 14 are perspective views depicting example embodiments ofthe delivery device.

FIGS. 15 and 16 are block diagrams depicting the deployment process ofan implantable device in accordance with some example embodiments of thepresent disclosure.

DETAILED DESCRIPTION

Overview

As previously mentioned, treatment options for BPH-related urinaryobstruction include medication and surgery. However, both treatmentoptions have many adverse side effects and risks. An alternativetreatment for BPH symptoms with fewer risks and side effects is to usean implantable device that mechanically holds open the urethra. FIG. 1illustrates an implantable device 100 implanted within the urethra inaccordance with some embodiments of the disclosure. In some embodiments,implantable device 100 can be a partially helical structure and can havetwo or more ring members (e.g., ring members 105 a, 105 b, and 105 c)and one or more connecting members (e.g. 110 a and 110 b). As shown,ring members 105 a, 105 b, and 105 c of implantable device 100 maintainurethra 120 in an open state. Device 100 can be manufactured in varioussizes as desired, such that the radius of each ring member 105determines the size of the opening, and the length of each connectingmember 110 determines the spacing between the ring members 105.

Implantable device 100 can be deployed into urethra 120 using a deliverydevice (described below) that can rotate implantable device 100 withrespect to a delivery sheath and concurrently expose it from within thedelivery device. In this way, the wall of the urethra is not irritatedby an abrupt pushing or scraping motion of the implantable device. Thegentle spinning deployment of implantable device 100 can also reduce therisk of tearing or rupturing the wall of the urethra. In otherembodiments, device 100 can be deployed without rotating it with respectto the delivery device. Once implantable device 100 is in place withinurethra 120, the delivery device can release implantable device 100.Depending upon the patient's condition and urethra anatomy, one or moreimplantable devices 100 or a different size (e.g., larger radius, longeraxial length) implantable device 100 can be implanted into urethra 120.

Implantable Device

FIG. 2 illustrates an implantable device 100 in accordance with someexample embodiments of the present disclosure. In this instance,implantable device 100 includes three ring members 105 a, 105 b, and 105c, and two connecting members 110 a and 110 b to form a bracing orscaffold-like structure. Connecting member 110 a bridges between ringmembers 105 a and 105 b and connecting member 110 b bridges between ringmembers 105 b and 105 c. To increase the ring member density ofimplantable device 100, additional rings 105 can be added and at thesame the length of the connecting members 110 can be shortened tomaintain the same overall length. Implantable device 100 also includes atermination member 215, which connects the last ring member (e.g., 105c) to end member 210.

Each of the connecting members 110 can be substantially parallel to acenter axis 220, which can be a common axis to each of the ring members105. In other words, each of the connecting members 110 a and 110 b issubstantially perpendicular to the planes of the ring members 105. Inthis embodiment, the plane of each ring member 105 is substantiallyparallel to the plane of other ring members 105 and is substantiallyperpendicular to common axis 220. In some embodiments, the plane of eachring member 105 can be angled with respect to common axis 200. Eachconnecting member 110 can also be angled with respect to common axis 200rather than being parallel. Connecting members 110 a and 110 b do nothave to be equal in length. For example, connecting member 110 a can bea first length (e.g., 6 mm) and member 110 b can be a second length(e.g., 7 mm). Ring spacing can be adjusted to improve stability,performance, and tissue support. As already stated, implantable device100 can have two or more ring members 105 and one or more connectingmembers 110, in alternating fashion, without departing from the scope ofthis disclosure.

In some embodiments, each ring member 105 is wound about axis 220 in anopposite direction of the winding direction of an adjacent ring member105. For example, ring member 105 a is wound in a first (e.g.,clockwise) direction and the next ring member 105 b is wound in a secondopposite (e.g., counterclockwise) direction. Finally, the last ringmember 105 c is wound in the first direction. In some embodiments, allring members 105 are wound in the same direction, clockwise orcounterclockwise.

Implantable device 100 can also include a distal end member 205 and aproximal end member 210. Each of members 205 and 210 can be an enlargedatraumatic shape such as rounded enlarged shape like a partial sphere,which serves two main functions. First, an atraumatic shape provides asmooth and non-abrasive contact surface with the urethra wall. Duringdeployment of implantable device 100, member 205 may rub against theurethra wall as implantable device 100 is being deployed. Thus, anatraumatic shape decreases the friction with the wall of urethra 120.When the surface area of member 205 or 210 is larger and preferablyrounded, it is less traumatic to the tissue as it distributes forcesacross a larger surface area. Also, an enlarged shape can provide asurface for a grasping component to hold implantable device 100. Thegrasping component can have a circular slot designed to engage and lockspherical member 205 or 210 in place. The grasping component can bedisposed at the distal end of the shaft (to be discussed later) of thedelivery device.

FIG. 3 illustrates an implantable device 100 in accordance with someembodiments of the present disclosure. In this embodiment, implantabledevice 100 includes four ring members 105 a, 105 b, 105 c, and 105 d.Each ring member 105 is separated by a connecting member (e.g., member110 a, 110 b, or 110 c). Each ring member 105 has an opposite windingdirection as compared to the one or two adjacent ring members 105. Forexample, ring member 105 a has a counterclockwise winding direction,ring member 105 b has a clockwise winding direction, and ring member 105c has a counterclockwise winding direction. Each ring member 305 canhave a common axis 220 and can be in a plane parallel to all other ringmembers 105.

Each of the connecting members 110 a, 110 b and 110 c can be parallel toaxis 220 or substantially normal to the plane of a ring member 105.Alternatively, each connecting member 110 can have angled (an angleother than 90 degree) with respect to the plane of the ring member 105or axis 320.

FIGS. 4A-4E illustrate a process of deploying implantable device 100into the urethra in accordance with some embodiments of the presentdisclosure. The process of deploying implantable device 100 can start byspiraling or spinning out ring member 105 a as shown in FIG. 4A. Next,connecting member 110 a is exposed by retracting sheath 405 (FIG. 4B)with respect to device 100, then second ring member 105 b can bedeployed by further rotating the shaft (not shown) connected toimplantable device 100 (FIG. 4C). In FIG. 4D, the second connectingmember 110 b can be exposed by again retracting sheath 405. Finally, thelast ring member 105 c can be spiraled or spun out. Once implantabledevice 100 is in position, the delivery device can release implantabledevice by retracting sheath 405 to expose the opening of the graspingcomponent located at the distal end of the shaft.

In other embodiments, sequential exposure of device 100 from withinsheath 405 can occur by advancing device 100 with respect to sheath 405as opposed to withdrawing sheath 405 as device 100 is held in a staticposition. In still other embodiments, exposure can occur by acombination of the two motions, where device 100 is moved distally whilesheath 405 is retracted proximally. In some embodiments, connectingmembers 110 a, 110 b, and 110 c can have variable lengths. In this way,the distance between any two ring members can be varied.

FIG. 4F illustrates implantable device 100 being housed within a distalregion of sheath 425 prior to being deployed in accordance with someembodiments of the present disclosure. Sheath 425 can have radialopenings (e.g., formed by cuts) to improve flexibility and/ordeliverability. In some embodiments, a grasper 450 is provided at theend of a shaft 460. Grasper 450 can include a slot having a shapecomplementary to the atraumatic end 210 of implantable device 100. Whenshaft 460 is rotated and translated, grasper 450 also rotates andtranslates, which in turn rotates and pushes implantable device 100 outof sheath 425. In other words, the combination of rotations andtranslations of shaft 460 cause corresponding rotations and translationsof implantable device 100, which cause implantable device 100 to gentlyspiral (or spin) out of sheath 425 and into the patient's urethra. Whenthe atraumatic end 210 of device 100, in the coupled state with grasper450, is exposed to the exterior from within the inner lumen of sheath425, end 210 and grasper 450 are freed from the restraint imparted bysheath 425 and no longer held in the coupled state, at which point end210 detaches from a pocket 475 of grasper 450 (see also FIG. 4G).

FIGS. 4G and 4H illustrate example embodiments of grasper 450 inaccordance with some embodiments of the present disclosure. As shown inFIG. 4G, grasper 450 includes a cavity/pocket 475 for holding the endportion (e.g., atraumatic member 210) of implantable device 100. FIG. 4Hshows implantable device 100 being attached to grasper 450. Whenimplantable device is not within sheath 425, atraumatic member 210 canbe released from (e.g., move out of) pocket 475 because it is no longerbeing constrained by the inner wall of sheath 425. Thus, once sheath 425is retracted, implantable device is released.

Delivery/Retrieval Device

FIG. 5A illustrates a delivery device 500 in accordance with someembodiments of the present disclosure. Delivery device 500 includes amain body 505, a front cap 507, and an end cap 510. Each of the mainbody 505, front cap 507, and end cap 510 has an internal cavity tocontain and enclose a camming barrel 515 and a knob 520. Main body 505can have an open substantially cylindrical shape such as a hollow tube.Front cap 507 can have a beveled surface with a narrow opening toenclose and secure an adapter shaft 523, which also can have a hollowinner portion to receive and contain a constraining sheath 425 (notshown, see FIG. 13). Adapter shaft 523 can also include a male luerfitting 527 to enable the attachment of various devices (e.g., acystoscope) to adapter shaft 523.

Camming barrel 515 can include a groove 530 on the surface of cammingbarrel 515. Groove 530 can be completely cut through the wall of cammingbarrel 515 to allow a cam follower 535 to fit through groove 530. Camfollower 535 can be securely (or rigidly) coupled to a shaft-driver body(not shown, see FIG. 5B), which is also securely coupled to shaft 460 ofdelivery device 500 (not shown, see FIG. 7A). FIG. 5B illustrates anexample embodiment cam follower 535 being coupled to shaft-driver body565. FIG. 5B also shows shaft 460 being rigidly coupled to shaft-driverbody 565. FIG. 5C is a close-up view of cam follower 535 disposed ingroove 530. Each cam follower 535 or 550 can have a T-shaped or I-shapedcross-section with the flange portion extending through and out of therespective anti-rotation slot (e.g., slot 537 or slot 560). Camfollowers 535 and 550 can have other shapes such as a cylinder forexample, while remaining within the scope of this disclosure.

Knob 520 is rotatably secured by main body 505 and is fixedly attachedto camming barrel 515. In some embodiments, knob 520 can be fixedlyattached to camming barrel 515, e.g., with a pin, such that if knob 520is rotated within main body 505, camming barrel 515 will also rotatealong with knob 520. For example, if knob 520 is rotatedcounterclockwise, camming barrel 515 will also rotate counterclockwise.Knob 520 can include indentations 521 (see also FIG. 7B) on the on thefront surface that interact with a plunger 522 affixed to front cap 507to provide audible clicks and haptic feedback to the user that the knobis successfully turning.

FIG. 6A illustrates delivery device 500 with knob 520 removed. In someembodiments, camming barrel 515 includes a second groove 540 located atthe distal end of camming barrel 515. Delivery device 500 also includesa second cam follower (e.g. a nut, pin, etc.) 550, which travels withingroove 540 when camming barrel 515 is rotated. As shown in FIG. 6A, camfollowers 535 and 550 are both in their respective starting position.Grooves 530 and 540 (and groove 1105 described later) can also bedescribed as slots or paths. The shapes of grooves 530, 540, and 1105can and will vary depending upon the particulars of the implementation.In some embodiments, the shapes of grooves 530, 540, and 1105 can bedescribed as forming a partially helical path.

Cam follower 535 starts at the proximal end (near end cap 510) ofcamming barrel 515 and ends at the distal end (near front cap 507) ofcamming barrel 515 at 543. In some embodiments, there are two endpositions for cam follower 535. Position 542 is the penultimate positionand position 543 is the very last position at the end of groove 530. Thegroove between penultimate position 542 and end position 543 is a radialslot 559 designed to allow camming barrel 515 to rotate but without anyaxial translation of shaft 460 (not shown, see FIG. 7A) or cam follower535.

In an initial setting of delivery device 500, cam follower 535 can beset to stop at penultimate position 542 such that it cannot move beyondposition 542 without requiring the user to unlock camming barrel 515.The locking mechanism that prevents cam follower 535 from moving frompenultimate position 542 to end position 543 will be described in detailbelow.

As shown, cam follower 550 starts at position 541 and moves topenultimate position 544 a as camming barrel 515 rotates. Once atpenultimate position 544 a, camming barrel 515 is rotationally locked bydefault to prevent cam follower 550 to move to end position 544 b.Similar to cam follower 535, cam follower 550 cannot move to endposition 544 b without requiring the user to unlock the lockingmechanism at the proximal end of camming barrel 515. This is to preventthe accidental release of implantable device 100 through the retractionof sheath 425.

In some embodiments, groove 530 can include multiple sloped (in somecases helical) and radial slots (e.g., slots 557 and 559 respectively),as well as other shapes, which can be linked together to form thedesired path (which in turns imparts desired movements to thecomponents). In the present description, certain sloped slots will bedescribed as helical, although the term helical is used broadly hereinand does not require a constant nor continuous slope. Indeed, thesesloped slots can vary such that the slope reverses from positive tonegative (like a “V”) if desired.

Groove 530 can have three or more helical slots and radial slots. Asloped slot can be an opening in camming barrel 515 with an angle thatmoves the slot along the longitudinal axis of camming barrel 515 duringrotation. A radial slot can include an opening perpendicular to thelongitudinal axis of camming barrel 515 such that the cam follower movesin the slot but is not translated in the longitudinal direction.

In some embodiments, the number of helical slots on camming barrel 515can correspond to the number of ring members 105 in implantable device100. Similarly, the number of radial slots on camming barrel 515 cancorrespond to the number of connecting members 110 in implantable device100 plus a termination member (e.g., member 215). For example, as shownin FIG. 2, implantable device 100 has three ring members (i.e., 105 a,105 b, and 105 c), two connecting members (i.e., 110 a and 110 b), andtermination member 215. Accordingly, groove 530 has three helical slots557 a, 557 b, 557 c and three radial slots 559 a, 559 b, 559 c (see FIG.6B). Here, each radial slot 559 is perpendicular to the longitudinalaxis of camming barrel 515. Thus, it can only rotate cam follower 535about the longitudinal axis of camming barrel 515 and does not cause anytranslation of cam follower 535 and/or shaft 460. Radial slot 559 canalso be described as a non-sloped slot. Since each helical slot 557 hasan axial translation component, it forces cam follower 535 (andshaft-driver body 565) to translate in the axial direction as cammingbarrel 515 rotates.

Cam follower 535 is configured to travel within groove 530 while stayingwithin a longitudinal slot 537 on main body 505. Longitudinal slot 537(see also FIG. 14) constrains cam follower 535 to only move in the axialdirection by preventing cam follower 535 to rotate along with cammingbarrel 515. In this way, cam follower 535 is forced to translate alongthe longitudinal axis of camming barrel 515 by slot 537.

In some embodiments, groove 540 is formed by chaining together aplurality of radial and helical slots. Grooves 530 and 540 can bearranged on camming barrel 515 such that when cam follower 535 istraversing a helical slot of groove 530, cam follower 550 isconcurrently traversing a radial slot of groove 540. Similarly, whilecam follower 535 is traversing a radial slot of groove 530, cam follower550 is concurrently traversing a helical slot of groove 540.

Stated differently, there are at least two main types of coordinatedmovement between cam followers 535 and 550. The first type ofcoordinated movement is when cam follower 535 is traversing a helicalslot of groove 530 while cam follower 550 is concurrently traversing aradial slot of groove 540. During the first coordinated movement, camfollower 535 and shaft 460 are being axially translated while camfollower 550 is concurrently traversing a radial slot (no axialmovement). This causes the sheath-driver body (see item 570 of FIG. 7A)to rotate about its own axis (or the longitudinal axis of camming barrel515) without any axial movement. In terms of the deployment, a portionof implantable device 100 is advanced out of sheath 425 during thisstage, while sheath 425 remains stationary because there is no axialmovement of the sheath-driver body.

The second type of coordinated movement involves cam follower 535traversing a radial slot of groove 530 while cam follower 550 isconcurrently traversing a helical slot of groove 540. During the secondtype of coordinated movement, cam follower 550 axially moves toward theproximal end of main body 550 while cam follower 535 remains axiallystationary. The axial movement of cam follower 550 is caused by therotation helical slot of groove 530, which pushes cam follower 550 alonga slot in anti-rotation sleeve 555. The slot in anti-rotation sleeve 555is parallel to the longitudinal axis of barrel 515. (This slot in sleeve555 is illustrated in FIG. 10A as item 650.) The effect of this motionis the retraction of sheath 425 into the lumen of camming barrel 515.

In some embodiments, cam followers 535 and 550 can move independently ofeach other. In other words, each of cam followers 535 and 550 may becoupled to a separate and discrete cam. In this way, cam follower 535can be moved in the distal direction while cam follower 550 canconcurrently be moved in the proximal direction instead of stayingaxially stationary.

FIG. 7A illustrates a cut-away view of camming barrel 515 to showinternal components of delivery device 500 in accordance with someembodiments of the disclosure. As shown, delivery device 500 can includea shaft 460, anti-rotation sleeve 555 (cut-away view), a shaft-driverbody 565, and a sheath-driver body 570. Shaft-driver body 565 isdisposed within a lumen 567 of camming barrel 515. Shaft-driver body 565can be sized to slidably fit into lumen 567 and to secure shaft 460along the longitudinal axis of camming barrel 515. Shaft 460 is rigidlycoupled to shaft-driver body 565 such that when shaft-driver body 565 istranslated and/or rotated within lumen 567, shaft 460 will experiencecorresponding translations and rotations. Shaft-driver body 565 is alsosecurely attached to cam follower 535, thus when cam follower 535 moveswithin groove 530, shaft-driver body 565 will rotate and translate asdictated by groove 530. As previously mentioned, slot 537 on main body505 is designed to constrain cam follower 535 such that cam follower 535can only move back and forth along the longitudinal axis of cammingbarrel 515.

Delivery device 500 can also include a sheath-driver body 570 that issecurely attached to sheath 425 and cam follower 550. Sheath-driver body570 includes a lumen to receive sheath 425 at an end close to the distalend of camming barrel 515. The lumen of sheath-driver body 570 can alsoreceive and pass-through shaft 460 into sheath 425. Sheath-driver body570 can be sized to slidably fit into the lumen of an anti-rotationsleeve 555, which is also appropriately sized to slidably holdsheath-driver body 570 such that the longitudinal axis of thesheath-driver body is along the longitudinal axis of camming barrel 515.In this way, when shaft 460 is translated toward the distal end ofcamming barrel 515, shaft 460 can be easily pass-through sheath-driverbody 570 and into sheath 425 (see also FIG. 7B).

FIG. 7B is a cut-out view depicting a portion of delivery device 100where knob 520 is located, but without anti-rotation sleeve 555. Asshown, sheath 425 terminates within sheath-driver body 570. However,sheath 425 has an opening at the termination end to allow shaft 460 topass through.

When camming barrel 515 rotates, groove 540 moves under cam follower 550and forces cam follower 550 to translate within the slot ofanti-rotation sleeve 555. The translation of cam follower 550 alsocauses sheath-driver body 570 to move proximally (toward shaft-driverbody 565). The translation of sheath-driver body in the proximaldirection causes sheath 425 to retract. Anti-rotation sleeve 555 can berigidly affixed to main body 505 using a pin and/or adhesive, or byusing an anti-rotation mechanical feature on the inner lumen of mainbody 505.

As shown in FIG. 7A, cam followers 535 and 550 are in their initialundeployed position. Once camming barrel 515 is rotated by rotating knob520 (not shown, see FIG. 5), cam follower 535 will traverse along groove530 toward penultimate position 542 and subsequently to end position 543(not shown, see FIG. 6A). In another perspective, as camming barrel 515rotates, groove 530 moves under cam follower 535, which is only allowedto move in the axial direction due to the constraint provided by slot537. As shown in FIG. 7A, slot 537 runs along main body 505, andparallel to the longitudinal axis of camming barrel 515, from a startingposition 705 to end position 543. While cam follower 535 moves towardend position 543, cam follower 550 moves within groove 540 and slot 650(not shown, see FIG. 10A) of anti-rotation sleeve 555 (see also FIGS. 6and 10A) from starting position 541 to penultimate position 544 a andsubsequently to end position 544 b (see also FIG. 6A).

FIG. 8A illustrates a cutout view of delivery device 500 near the end ofthe rotation/deployment procedure. FIG. 8B illustrates a partial cutoutview of delivery device 500 near the end of the rotation/deploymentprocedure. Once camming barrel 515 is rotated until cam follower 535reaches the end of groove 530 (at position 543), shaft-driver body 565is located near the distal end of camming barrel 515 and is closer tosheath-driver body 570, which has moved toward the proximal end ofcamming barrel 515 (closer to shaft-driver body 565).

FIG. 9 is a perspective view of delivery device 500 near the end of therotation/deployment procedure with main body 505 in a cut-away view. Asshown, cam follower 550 is at its penultimate position 544 a. Camfollower 550 is prevented to move to end position 544 b until end cap510 is actuated to allow camming barrel 515 to be further rotated. Endcap 510 also serves as an actuatable barrel portion, when actuated,actuatable barrel 510 either prevents or enables camming barrel 515 tofurther rotate after cam follower 550 has reached position 544 a. Morediscussion of the actuatable barrel and its related components will beprovided below.

As cam follower 550 moves toward the proximal end of camming barrel 515,cam follower 550 also causes sheath-driver body to proximally translateand thereby pulling the rigidly attached sheath 425 (not shown, FIG. 7A)toward the proximal end of camming barrel 515. When sheath 425 is pulledback into the body of camming barrel 515, a portion of implantabledevice 100 (e.g., connecting member 110 a) is exposed at the end ofsheath 425. However, as mentioned, once cam follower 535 reachespenultimate position 544 a, camming barrel 515 is locked and camfollower 550 cannot move to end position 544 b of groove 540 untilactuatable barrel 510 is actuated to release camming barrel 515 andallow it to be further rotated. This final movement of cam follower 550between penultimate position 544 a to position 544 b causes sheath 425to further retract into the lumen of camming barrel 515 and therebyexpose grasping portion 450 (see FIGS. 4F-H) of shaft 460. Once graspingportion 450 is exposed, implantable device 100 is freed and releasesfrom delivery device 500.

FIGS. 10A-10N depict the positions and movements of various componentsof delivery device 500 during the deployment process in accordance withsome embodiments of the present disclosure. The start of the deploymentprocess for implantable device 100 is illustrated by FIG. 10A where camfollower 535 and shaft-driver body 565 are at the starting/defaultposition. At the distal end of camming barrel 515, sheath-driver body570 is near the distal end of camming barrel 515. Shaft-driver body 565and sheath-driver body 570 are farthest away from each other at thisstage. Extending out of the end of adapter shaft 523 (see FIG. 5A) issheath 425, which extends from sheath-driver body 570 within the lumenof camming barrel 515 to beyond the exit opening of adapter shaft 523.FIG. 10B illustrates sheath 425 in the initial configuration—beforedeployment of implantable device 100. Here, implantable device 100 iscompletely embedded within sheath 425.

FIG. 10C illustrates the first stage of deployment where ring member 105a is spiraled or spun out of sheath 425 (see FIG. 10D). As shown in FIG.10C, shaft-driver body 525 and cam follower 535 have moved to a newposition at 1005. This is caused by the rotation of camming body 515,which can be done by rotating knob 520 (not shown, see FIG. 5A). Whencamming barrel 515 is rotated, cam follower 535 traverses along groove530 and thereby causes shaft-driver body 565 to correspondingly rotateand translate. The rotation and translation of shaft-driver body 565also causes shaft 460 to rotate and translate, which in turn causes ringmember 105 a of implantable device 100 to rotate and translate out ofsheath 425 (FIG. 10D). The rotation of camming barrel 515 also causescam follower 550 to simultaneously move within groove 540 at the distalend of camming barrel 515.

Between the positions of FIG. 10C and FIG. 10E, cam follower 535 moveswithin a radial portion of groove 530. During the traversal of theradial portion, shaft-driver body 565 rides in the radial portion ofgroove 530 to maintain its axial position (i.e., without any axialtranslation). At the same time, cam follower 550 moves within a helicalportion of groove 530 toward the proximal end of camming barrel 515.This causes cam follower 550 to push sheath-driver body toward theproximal end of delivery device 500 and in turn retract sheath 425 intothe body of camming barrel 515. FIG. 10F illustrates the exposure ofconnecting member 110 a as sheath 425 is being proximally retracted.

FIG. 10G illustrates second ring member 105 b being pushed out of sheath425 (see FIG. 10H). As shown in FIG. 10G, shaft-driver body 565 and camfollower 535 have moved to a new position 1010. During the transitionbetween positions 1005 and 1010, second ring member 105 b is deployedinto the patient's urethra as depicted in FIG. 10H. While cam follower535 is traversing between positions 1005 and 1010, cam follower 550simultaneously traverses a radial slot of groove 540. This movement haszero axial component, which thereby causes sheath-driver body 570 toremain proximally stationary.

Between FIGS. 10G and 101, cam follower 535 traverses a radial slotportion (blocked from view by cam follower 535 and shaft-driver body525). The radial slot portion of groove 530 (that is blocked from view)is similar to radial slot 1050, which is the radial slot of a previousradial transition between FIGS. 10C and 10E. At the same time, camfollower 550 traverses a helical slot of groove 540 as shown by arrow1015. This movement has an axial component and thus causes sheath-driverbody 570 to retract in the proximal direction (toward shaft-driver body525). The additional retraction of sheath 425 further exposes connectingmember 110 b of implantable device 100 (see FIG. 10J).

Between FIGS. 10I and 10K, third ring member 105 c is pushed out as camfollower 535 traverses the last helical portion of groove 530. FIG. 10Lillustrates ring member 105 c in the deployed position.

FIGS. 10K and 10M illustrate the last stage of deployment of implantabledevice 100. During this stage, cam follower 535 traverses a radial slotof groove 530 from penultimate position 542 to end position 543 (notshown, see FIG. 6A). At the same time, cam follower 550 traverses ahelical slot of groove 540 from penultimate position 544 a to endposition 544 b. In an initial setting of delivery device 500, both camfollowers 535 and 570 are prevented to traverse from their respectivepenultimate position to the end position as camming barrel 515 is lockedby a locking mechanism located at the proximal end of camming barrel515.

In some embodiments, delivery device 500 does not include groove 530,and only helical groove 540 is present. In this embodiment, implantabledevice 100 does not need to be spun (or pushed) out of sheath 425.Instead, the deployment procedure involves only retracting sheath 425 toslowly expose implantable device 100 contained within sheath 425 (whichis partially shown in FIG. 10N).

FIGS. 10K, 11, 12A-C, and 13 will be described together to furtherillustrate the locking mechanism. FIG. 11 depicts camming barrel 515 inaccordance with some embodiments of the present disclosure. FIGS. 12Aand 12B depict various internal components of the locking mechanism, andFIG. 13 depicts a cross-section of delivery device 500 in accordancewith some embodiments of the present disclosure. The locking mechanismincludes a third groove 1105 (see FIG. 11) at the proximal end ofcamming barrel 515, end cap 510, a cam follower 1055 (see FIG. 10K), anda locking sleeve 1205 (see FIG. 12A). As shown in FIG. 11, cammingbarrel 515 includes groove 1105, which drives cam follower 1055 alonglocking sleeve 1205 as camming barrel 515 is being rotated by knob 520.Upon deployment of implantable device 100 or the clockwise rotation ofcamming barrel 515, locking sleeve 1205 moves toward the proximal end ofcamming barrel 515. Once cam followers 535 and 550 reach theirrespective penultimate position, notch 1215 of locking sleeve 1205engages pin 1210 (see FIG. 12B), which is rigidly attached to actuatableend cap 510. This can prevent the accidental deployment of implantabledevice 100. Once camming barrel 515 is allowed to further rotate, camfollower 550 will move to end position 544 b. This will cause sheath 425to retract and expose grasping portion 450 of shaft 460. The exposure ofthe grasping portion will free end member 210 of implantable device 100from the confines of sheath 425 (see FIG. 10N). This effectively endsthe deployment procedure as implantable device 100 is released fromgrasping portion 450.

FIGS. 12D-12I are perspective and semi-transparent views of the lockingmechanism during the deployment progression of implantable device 100.FIGS. 12D, 12E, and 12F correspond with the deployment progression asdepicted in FIGS. 10A, 10B, and 10C, respectively. FIGS. 12G, 12H, and12I correspond with the deployment progression as depicted in FIGS. 10A,10B, and 10C, respectively. FIGS. 12H and 12I also correspond with thedeployment progression as depicted in FIGS. 12B and 12C, respectively.

FIG. 12J is a cut-away view of the locking mechanism in accordance withsome embodiments of the present disclosure. In some embodiments, end cap510 is actuatable because pin 1235 can be moved along the longitudinalaxis of camming barrel 515. In the initial setting (also a defaultsetting), pin 1235 is biased toward the distal end of camming barrel 515(see FIGS. 12A and 12B). During deployment, cam follower 1055 movesproximally via the helical path 1105, until it reaches the penultimatelock position. The L-shaped slot of end cap 510 is designed to axiallyreceive pin 12354 and locking sleeve 1205. The longer the axial lengthof the slot of end cap 510, the further camming barrel 515 can rotatebefore notch 1215 of locking sleeve engages pin 1210.

FIG. 12B illustrates the position of sleeve 1205 and notch 1215 withrespect to pin 1210 when cam followers 535 and 550 are at theirpenultimate positions. As shown, pin 1210 engages notch 1215 whichprevents camming barrel 515 from further rotation because cam follower1055 is rigidly affixed to sleeve 1205. Again, this can prevent theaccidental release of implantable device 100 until end cap 510 isactuated by pushing (or pulling) the end cap handle 1230 toward theproximal direction.

FIG. 12C illustrates when end cap 510 is actuated and final rotation(release) is completed. As shown, pin 1210 is pulled by the user towardthe proximal end of end cap 510. Since pin 1210 is no longer preventingcam rotation, camming barrel 515 may further rotate (clockwise), whichmoves cam follower 1055 to the radial end of the L-shaped slot of endcap 510. In many embodiments, this ends the implantable devicedeployment procedure.

FIG. 14 illustrates a perspective view of a fully assembled deliverydevice 500 in accordance with some embodiments of the presentdisclosure. As shown, delivery device 500 includes a drainage assembly1405 for draining fluid within the urethra during the deployment ofimplantable device 100. Assembly 1405 can also be used to flush or addfluid during the procedure.

FIG. 15 illustrates a process 1500 for deploying an implantable device(e.g., implantable device 100) in accordance with some embodiments ofthe present disclosure. Process 1500 can start at 1505 where a sheath(e.g., sheath 425) containing the implantable device 100 is insertedinto a patient's urethra. At 1510, to deploy the implantable device, thecam of the delivery device (e.g., delivery device 500) is rotated. Thiscan be done by turning a knob (e.g., knob 520) of the delivery device500, for example. Alternatively, the camming barrel (e.g., cammingbarrel 515) of the delivery device 500 may be directly rotated. At 1515,sheath 425 is driven backward, which causes sheath 425 to retract intothe body of delivery device 500. As sheath 425 is slowly beingretracted, implantable device 100 is slowly exposed and deployed withinthe urethra. Once implantable device 100 is fully deployed and released,sheath 425 is removed from the patient's body at 1520.

FIG. 16 illustrates a process 1600 for retracting sheath 425 and forspiraling out implantable device 100 in accordance with some embodimentsof the present disclosure. Process 1600 starts at 1605 where a first camfollower (e.g., cam follower 535 or 550) is moved (rotated and/ortranslated) within a first groove (e.g., groove 530 or 540). In someembodiments, the first cam follower is constrained to only move in theaxial direction. This can be accomplished using a slot disposed parallelto the longitudinal axis of the main body of the delivery device (e.g.,main body 505 or camming barrel 515). An anti-rotation sleeve with alongitudinal slot may also be employed to restrict the movement of thecam follower. At 1610, when the first cam follower (e.g., cam follower535) is being moved within the first groove, the second cam follower(e.g., cam follower 550) is also concurrently moved within the secondgroove. In some embodiments, while the first cam follower is movingwithin a helical slot portion of the first groove, the second camfollower is concurrently moving within a radial slot portion of thesecond groove. Additionally, while the first cam follower is movingwithin a radial slot portion of the first groove, the second camfollower is concurrently moving within a helical slot portion of thesecond groove. In this way, the movements of both cam followers 535 and550 are not the same at any point of time. This also enables two maintypes of coordinated movement. The first type is when the first camfollower pushes shaft 425 in the distal direction while the second camfollower holds sheath 425 axially stationary. The second type is whenthe first cam follower holds shaft 425 axially stationary while thesecond cam follower retracts sheath 425 in the proximal direction.

In certain situations, it may be desirable to return implantable device100 to its housed position within sheath 425 prior to device 100 beingfully released from grasper 450. For example, if the medicalprofessional views the partially deployed location or position ofimplantable device 100 as not optimal or otherwise desirable, thenimplantable device 100 can be partially or fully retracted into sheath425 (or sheath 425 can be advanced over device 100, or a combination ofboth movements) by performing one or more steps of the deploymentprocedures as described herein (e.g., with respect to FIGS. 4A-4E and10A-10N) in reverse order. For example, each deployment step executed toexpose a portion of device 100 (e.g., a portion of a first ring 105, afirst ring 105 and a portion of a connecting member 110, multiple rings105 and an intervening connection member 110, and so forth) from theopen distal end of sheath 425 can be performed in reverse, with theoverall sequence of executed steps also being performed in reverse. Forexample, if the delivery embodiment is configured such that rotation ofcamming barrel 515 (or knob 520) in a first (e.g., counter-clockwise)direction causes a portion of implantable device 100 to exit the opendistal end of sheath 425, then rotation of camming barrel 515 (or know520) in a second opposite (e.g., clockwise) direction causes the exposedportion of implantable device 100 to return to the housed positionwithin sheath 425 and thereby recover implantable device 100. Deliverydevice 500 can then be repositioned (e.g., without removing from thebody) and the delivery procedure can be started anew. This process canbe repeated until an optimal or desirable placement is achieved, atwhich point implantable device 100 can be fully released and separatedfrom delivery device 500.

It should be noted that all features, elements, components, functions,and steps described with respect to any embodiment provided herein areintended to be freely combinable and substitutable with those from anyother embodiment. If a certain feature, element, component, function, orstep is described with respect to only one embodiment, then it should beunderstood that that feature, element, component, function, or step canbe used with every other embodiment described herein unless explicitlystated otherwise. This paragraph therefore serves as antecedent basisand written support for the introduction of claims, at any time, thatcombine features, elements, components, functions, and steps fromdifferent embodiments, or that substitute features, elements,components, functions, and steps from one embodiment with those ofanother, even if the following description does not explicitly state, ina particular instance, that such combinations or substitutions arepossible. It is explicitly acknowledged that express recitation of everypossible combination and substitution is overly burdensome, especiallygiven that the permissibility of each and every such combination andsubstitution will be readily recognized by those of ordinary skill inthe art.

In many instances entities are described herein as being coupled toother entities. It should be understood that the terms “coupled” and“connected” (or any of their forms) are used interchangeably herein and,in both cases, are generic to the direct coupling of two entities(without any non-negligible intervening entities) and the indirectcoupling of two entities (with one or more non-negligible interveningentities). Where entities are shown as being directly coupled together,or described as coupled together without description of any interveningentity, it should be understood that those entities can be indirectlycoupled together as well unless the context clearly dictates otherwise.

As used herein and in the appended claims, the singular forms “a,” “an,”and “the” include plural referents unless the context clearly dictatesotherwise.

The examples and embodiments provided herein are provided forillustrative purposes and are not intended to limit the application orclaims provided herein. It will be understood that the specificembodiments disclosed herein and the systems, components, methods, etc.described herein need not take the specific form described, but caninstead be applied in various different or additional manners consistentwith the present disclosure and claims. It will further be understoodthat the present disclosure need not take the specific form explicitlydescribed herein, and the present disclosure is intended to includechanges variations thereof, consistent with the appended claims and thepresent disclosure, for example, to optimize the subject matterdescribed herein. The disclosed subject matter is not limited to anysingle or specific embodiment described herein, but rather should beconstrued in breadth and scope in accordance with the appended claims.

The invention claimed is:
 1. A method for deploying an implantabledevice with a delivery device comprising a sheath, the methodcomprising: inserting the sheath containing the implantable device intoa patient's body, wherein the sheath is coupled along a longitudinalaxis of the delivery device; rotating a cam of the delivery device suchthat the sheath is retracted as the cam is being rotated and theimplantable device is exposed from the sheath, wherein rotating the camcomprises rotating a camming barrel having a first groove at a distalend of the camming barrel, wherein rotating the camming barrel causes afirst cam follower coupled to the sheath to travel along the firstgroove and to translate the sheath, wherein the translation of thesheath causes the sheath to retract into the camming barrel; andretracting a handle to disengage a locking mechanism, thereby permittingfurther rotation of the camming barrel.
 2. The method of claim 1,wherein rotating the camming barrel further comprises a second groovedisposed on the camming barrel, coupled with a second cam follower toforce the second cam follower to axially move toward a distal end of thecamming barrel, wherein the second cam follower is coupled to a shaftand wherein the axial movement of the second cam follower causes theshaft to move in a distal direction.
 3. The method of claim 2, whereinthe first and second groove each comprises a plurality of helical andradial slots.
 4. The method of claim 3, wherein rotating the cammingbarrel causes the first cam follower to move in a radial slot of thefirst groove and concurrently causes the second cam follower to move ina helical slot of the second groove.
 5. The method of claim 3, whereinrotating the camming barrel causes the first cam follower to move in ahelical slot of the first groove and concurrently causes the second camfollower to move in a radial slot of the second groove.
 6. A method fordeploying an implantable device with a delivery device comprising asheath, the method comprising: inserting the sheath containing theimplantable device into a patient's urethra, wherein the implantabledevice is coupled to a shaft along a longitudinal axis of the deliverydevice; rotating a cam of the delivery device such that the shaft istranslated as the cam is being rotated, wherein rotating the cam of thedelivery device comprises rotating a camming barrel having a firstgroove at a proximal end of the camming barrel, wherein rotating thecamming barrel causes a first cam follower coupled to the shaft totravel along the first groove and to axially translate the shaft in adistal direction; and retracting a handle to disengage a lockingmechanism, thereby permitting further rotation of the camming barrel,wherein the translation of the shaft pushes the implantable device outof the sheath and into a position for maintaining the urethra in an openstate.
 7. The method of claim 6, wherein the camming barrel furthercomprises a second groove coupled with a second cam follower, the methodfurther comprising rotating the camming barrel to force the second camfollower to axially move toward a proximal end of the camming barrel,wherein the second cam follower is coupled to the sheath and wherein theaxial movement of the second cam follower causes the sheath to move in aproximal direction.